The latest face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan on 1-2 October 2019. WHO participated as observer. The PDG 30th Anniversary Symposium was also held on 3 October 2019.
Individual work programme sign-offs at this meeting included revisions to monographs on E-55 Gelatin and E-60 Sodium Lauryl Sulfate. The PDG monograph on Gelatin now covers all grades, while the monograph on Sodium Lauryl Sulfate has been revised to include a new Identification by infrared spectrophotometry and a revised Assay method. It was also reported that the revision to Q-07 Colour was signed off by correspondence in June 2019.
Thus 28 of the 31 General Chapters and 46 of the 60 excipient monographs on the current work programme have now been harmonised among the PDG Pharmacopoeias. In-depth discussions on other items on the current PDG work programme also took place with a view to resolving outstanding issues and advancing the items towards sign-off. In addition, the Coordinating Pharmacopoeia reported back on the success of the technical teleconference in July 2019 on the revision of Q-09 Particulate Contamination.
More detail in the press release.
Remarks by Susanne Keitel, Director of the EDQM, at the 30th Anniversary of the Pharmacopoeial Discussion Group (PDG). EDQM: transparency and dialogue are key in achieving pharmacopoeial harmonisation.